At WuXi XDC, we leverage in-house expertise and state-of-the-art analytical equipment to characterize the distinct intermediates (e.g., protein/mAb, payload and linker) and the bioconjugate including antibody drug conjugate (ADC) therapeutic candidates or diagnostic and imaging reagents at various stages of development. Methods utilized to assess and characterize these complex bioconjugated molecules include UV/VIS, HPLC, cIEF, LC-MS amongst others as is analytical assessment of drug-to-antibody ratio, free-drug content, ADC affinity, protein concentration, aggregation, PI, and peptide mapping. Methods utilized to assess and characterize these complex bioconjugated molecules include (but are not limited to):
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- Drug-to-Antibody Ratio
- Conjugation Efficiency
- Aggregation
- Free Drug Residue
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- Aggregation
- Nanoparticle Characterization
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- Drug-to-Antibody Ratio
- Conjugation Efficiency
- Free Drug Residue
- Peptide Mapping
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- Ligand Binding/Affinity
- In vitro Potency Test
- Capillary Electrophoresis (CE) and Capillary Isoelectric Focusing (CIEF)
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- Non-Reduced & Reduced (CE-SDS)
- Determination of pI (cIEF or iCIEF)
- UV/Vis (NanoDrop and SoloVPE®)
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- Protein Concentration
- Drug-to-Antibody Ratio
Additional Bioconjugate Characterization Capabilities:
- Capillary Electrophoresis (Charge Heterogeneity and Product-related Impurities)
- Native MS (Intact Molecular Weight Determination under Native Conditions)
- Peptide Mapping (Conjugated Sites and Occupancy)
- Accurate Kd Determination
Formulation and Drug Product Development
We offer extensive end-to-end services for formulation/process development for a wide variety of bioconjugates. Our team assists from early-stage molecular assessments to development of First-in-Human (FIH) formulations to enable clinical trial starts. Additionally, we further provide commercial formulations lock and process/device development in preparation for product launches.
We are experts in developing liquid, frozen or lyophilized dosage forms filled into vials as well as special dosage forms for products containing nanoparticles and other advanced molecular complexes.